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A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

2012-09

2015-06

2015-06

150

Study Overview

A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

  • Head and Neck Cancer
    • Kidney Safety - Cisplatin

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2013-08-29  

    N/A  

    2015-01-23  

    2013-09-03  

    N/A  

    2015-01-27  

    2013-09-06  

    N/A  

    2014-07  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A

    Allocation:
    N/A

    Interventional Model:
    N/A

    Masking:
    N/A

    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : head & neck cancer patients, cisplatin treatment

    : cancer patients, no cisplatin, no nephrotoxic agent

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    biomarker change from baselineup to 3 weeks
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Study Contact

    Name: Stefan Sultana, MD

    Phone Number:

    Email: stefan.sultana@novartis.com

    Study Contact Backup

    Name: Jessica Ratay, MS

    Phone Number: (301) 435-4038

    Email: jratay@fnih.org

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      Inclusion Criteria (Cisplatin Treatment Group):
      1. Males and females ≥ 18 years of age 2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:

    • as single agent chemotherapy in conjunction with local radiotherapy course, or
    • as part of the TPF combination (docetaxel, cisplatin, and fluorouracil) 3. Willingness and ability to comply with study procedures and study restrictions 4. Ability to provide written informed consent

      • Inclusion Criteria (Control Group):
      1. Males and females ≥ 18 years of age 2. Diagnosis of head & neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone) 3. Willingness and ability to comply with study procedures and study restrictions 4. Ability to provide written informed consent
      Exclusion Criteria (All Subjects):
      1. Chronic kidney disease defined by eGFR <60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (>30 mcg/mg creatinine) will be excluded 2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi) 3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month 4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine 5. Use of creatine supplements within 7 days prior to hospitalization 6. Solid organ transplant recipients 7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN) 8. Significant anemia (Hemoglobin < 10 g/dL) 9. Pregnancy 10. Institutionalized individuals

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.

    • University of Southern California
    • University of Minnesota
    • M.D. Anderson Cancer Center
    • Brigham and Women's Hospital
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    • Amgen
    • AstraZeneca
    • Eli Lilly and Company
    • Johnson & Johnson
    • Merck Sharp & Dohme LLC
    • Pfizer
    • Critical Path Institute - Predictive Safety Testing Consortium
    • PRINCIPAL_INVESTIGATOR: Abdulla Salahudeen, MD, University of Texas MD Anderson

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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